Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Real-world Study: Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683445
• Other study ID #: 2020-KY-064
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Jianli Dr. Zhao, doctor
• Phone: 86-20-34070870
• Email: zhaojli5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chemotherapy is an important means to prolong the survival time of advanced breast cancer. As a new type of microtubule inhibitor, eribulin has a unique mechanism of action. Compared with single drug chemotherapy, it can improve the overall survival time of 2.5 months, increase the clinical benefit rate by 5 times, and the tolerance of eribulin is good. Therefore, the guidelines at home and abroad recommend eribulin for the rescue of advanced breast cancer. However, up to now, there is no large sample data on the efficacy of eribulin combined with anti HER2 targeted therapy in HER2 + metastatic breast cancer, and the efficacy of combined immunotherapy in triple negative metastatic breast cancer. Moreover, as a newly marketed chemotherapy drug in China, the efficacy and safety data of eribulin in Chinese population are relatively lacking. Therefore, we plan to include different types and line numbers of advanced breast cancer patients based on the Chinese population through real-world research, and receive the treatment regimen containing eribulin respectively. In HR + / her2-mbc, we use eribulin monotherapy; in HER2 + MBC, we use eribulin + anti HER2 targeted therapy; in TNBC, we use eribulin + immunotherapy / chemotherapy, The efficacy and safety of eribulin were evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adult female patients (aged 18-80 years, including 18 and 80 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;

2. The starting time of eribulin treatment was between January 2021 and December 2021;

3. They received no more than 2-line chemotherapy in the past;

4. In HR + / her2-mbc, patients were treated with eribulin monotherapy; in HER2 + MBC, patients were treated with eribulin + anti HER2 targeted therapy; in TNBC, patients were treated with eribulin + immunotherapy / chemotherapy; in patients with HER2 + MBC, patients were treated with eribulin + immunotherapy /chemotherapy;

Exclusion Criteria:

1. Patients without pathological diagnosis;

2. Patients with central nervous system metastasis;

3. She has received more than two chemotherapy regimens for metastatic breast cancer;

4. Participating in any intervention drug clinical trials.

5. Those who have been known to have allergic history to the components of this regimen;

6. The patient, the patient, or the person with serious harm to the safety of the study.

7. Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Eribulin
Eribulin,1.4mg/m2,Intravenous infusion,d1,d8,3-week cycle
• Trastuzumab
Trastuzumab,8mg/kg for the first dose,6mg/kg for the following dose,Intravenous infusion,3-week cycle
• pertuzumab
Pertuzumab,,840mg for the first dose,420mg for the following dose,Intravenous infusion,3-week cycle
• Pyrotinib
Pyrotinib,400mg,oral,every day
• Pembrolizumab
Pembrolizumab,200mg,Intravenous infusion,3-week cycle
• Camerlizumab
Camerlizumab,200mg,Intravenous infusion,3-week cycle

Locations

Country	Name	City	State
China	Sun Yat Sen Memorial Hospital,Sun Yat sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20. — View Citation

Kimura K, Iwamoto M, Tanaka S, Yamamoto D, Yoshidome K, Ogura H, Terasawa R, Matsunami N, Takahashi Y, Nitta T, Morimoto T, Fujioka H, Kawaguchi K, Uchiyama K. A phase II, multicenter, single-arm trial of eribulin as first- or second-line chemotherapy for — View Citation

Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander GC, Omar A, Ford DE; National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee. Clinical trial registration and reporting: a survey of academic organ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Partial remission, PR	the diameter of target lesions diminished more than 30% and lasted for 4 weeks	up to 12 month
Other	Disease stable, SD	the sum of the maximum diameter of the target lesion is smaller than PR, or the increase is not up to PD	up to 12 month
Other	Disease progression, PD	he sum of the maximum diameter of the target lesion increased by at least 20%, and its absolute value increased by at least 5 mm, New lesions are also considered as PD	up to 12 month
Other	Objective response rate , ORR	according to recist1.1 criteria, the proportion of patients whose best remission is CR or PR in the total number of evaluable patients.	up to 12 month
Other	Clinical benefit rate, CBR	according to recist1.1 criteria, the proportion of patients with Cr or PR or SD = 24 weeks in the total number of evaluable patients.	up to 12 month
Other	Exploration of biomarkers	Objective to explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on.	the first week after the enrollment
Other	the rate of adverse events	The probability and severity of adverse reactions were analyzed up to 2 year after enrollment	up to 24 month
Primary	Progression Free Survival,PFS	The time from the beginning of treatment to the progression or death of the patient	up to 24 month
Secondary	overall survival,OS	The time from the beginning of treatment to the death of the patient	up to 36 month
Secondary	Quality of life scale score,QoL	The quality of life score of patients during treatment was analyzed(FACT-B). Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale) Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale)	up to 24 month
Secondary	Complete remission, CR	all target lesions disappeared, no new lesions appeared, and tumor markers were normal, which lasted for at least 4 weeks	up to 12 month